Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) (BICAFMS)

May 11, 2026 updated by: University Hospital, Bordeaux

Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.

Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Caen, France, 14033
        • CHU de Caen
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand
      • Dijon, France, 21079
        • Hôpital du Bocage
      • Dunkirk, France, 59385
        • CH de Dunkerque
      • Lille, France
        • Hôpital Roger Salengro
      • Lille, France, 59020
        • Centre Hospitalier Saint Vincent de Paul
      • Marseille, France, 13385
        • CHU de Marseille
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nancy, France, 54035
        • CHU de Nancy
      • Nice, France, 06002
        • CHU de Nice
      • Paris, France, 75970
        • Hopital Tenon
      • Poissy, France, 78303
        • Hôpital de Poissy Saint Germain
      • Reims, France, 51092
        • Chu de Reims
      • Strasbourg, France, 67200
        • CHU de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients :

  • Aged 18-64 years
  • Francophone
  • MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • Being affiliated to health insurance

Controls:

  • Aged 18-64 years
  • Francophone
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • Being affiliated to health insurance

Exclusion Criteria:

Patients:

  • Other neurological diseases with impact on cognitive functions.
  • Severe psychiatric disease or severe depression.
  • Current Dependence on alcohol or drugs.
  • Modification or stop of psychotropic treatment in less than a month.
  • Modification of MS treatment in less than a month.
  • Visual, visual-motor and / or motor impairments excluding the ability to perform cognitive tests.
  • Pregnant

Controls:

  • Neurologic disease and known chronic systemic with impact on cognitive functions.
  • Severe psychiatric disease or severe depression.
  • Current Dependence on alcohol or drugs.
  • Psychotropic treatment
  • Cognitive complaint
  • Prior cognitive testing with the same tests less than one year.
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
healthy subject
Behavioral: Cognitive evaluation
  • Questionnaires for assessment of confounding factors
  • Cognitive evaluation
  • Walking tests and 9 Hole Peg Test
Experimental: Patient
MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Behavioral: Cognitive evaluation
  • Questionnaires for assessment of confounding factors
  • Cognitive evaluation
  • Walking tests and 9 Hole Peg Test
Behavioral: Expanded Disability Status Scale (EDSS) score
- EDSS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
Time Frame: At the inclusion (Day 0)
average z scores of CEVMT and CSCT
At the inclusion (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education
Time Frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
BCCAMS and MACFIMS
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory
Time Frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
California verbal learning test-II and brief-visual memory test-revised
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)
Time Frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
congnitive test
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Prediction between cognitive impairment and occupational status/leisure activities
Time Frame: At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
questionnaire
At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue
Time Frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
scale
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis
Time Frame: At 1 and 6 months after the inclusion (Day 0)
congnitive test
At 1 and 6 months after the inclusion (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2015

Primary Completion (Actual)

February 18, 2018

Study Completion (Actual)

February 18, 2018

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimated)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/23
  • 2014-A01646-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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